Drug importation is dangerous and won’t lower prices
Federal and state governments continually insert themselves into the medical marketplace in an attempt to lower prescription drug costs. Some of these proposals sound good, like drug importation, but they are really a wolf in sheep’s clothing. Importation is often portrayed as a “free trade” policy that would allow countries to sell drugs in the U.S. at a lower price and offer more options for patients. But this is a false representation of drug importation.
The Food and Drug Administration (FDA), which has been called the gold standard of determining drug safety and effectiveness, estimates that nearly 99.1 percent of drug products entering the U.S. through international mail in 2019 were non-compliant with agency standards, and 10 percent of medicines worldwide are estimated to be counterfeit. Drug importation would open the floodgates to unregulated drugs, which puts patients at risk. Drug importation also puts global-leading U.S. biopharmaceutical innovation at risk by oversaturating the market with foreign drugs that are inflicted with socialist price controls.
As Citizens Against Government Waste noted in its March 5, 2020, comments to the FDA on its proposed rule for importation of prescription drugs, the FDA had refused since 2000 to certify the safety of imported drugs. President Bill Clinton’s Secretary of Health and Human Services Donna Shalala stated in December 2000 that it was “impossible for me to demonstrate that it is safe and cost-effective” to import drugs from foreign countries. In his Nov. 17, 2015, testimony at the Senate Committee on Health, Education, Labor and Pensions hearing on his nomination as FDA commissioner, Robert Califf (the current FDA commissioner) stated that importation would undermine the “closed drug distribution system in the United States” and make “it easier for unapproved drugs, which may include counterfeit or other substandard drugs, to reach American patients putting their treatment at risk.” He said, “the risks of unapproved products from foreign sources outweigh any potential cost savings.”
On May 18, 2018, HHS Secretary Alex Azar reiterated the FDA’s opposition when he noted the prior four FDA commissioners said that drugs from Canada cannot be guaranteed to be coming from that country rather than China, and that the U.S., which “has the safest regulatory system in the world” cannot “open borders for unsafe drugs in search of savings that cannot be safely achieved.” He noted that claims that seniors can save money by importing drugs “is a gimmick” that “has been assessed multiple times by the Congressional Budget Office, and CBO has said it would have no meaningful effect.”
Even if the FDA approved drug importation, Canadian authorities have made it clear they have no interest in exporting drugs to the United States. A Jan. 16, 2020, Canadian Financial Post article stated that drug manufacturers “are unlikely to permit their Canadian wholesalers or distributors to undercut their prices in the U.S. by exporting drugs that they have supplied specifically for the Canadian market. Indeed, the wholesalers may be contractually prohibited from exporting any product they purchase from manufacturers” and the Canadian “federal government has already vowed to protect Canadians’ drug supplies and access to medication.”
It seems very likely that there will be no drugs coming south from our neighbor to the north. And the importation of drugs from any country with socialized medicine imports all of the negative consequences of those systems, including price controls and rationing care.
Instead of wasting time and money on dangerous and faulty importation proposals, Congress should encourage the FDA to speed up the drug approval process and reduce the cost of program and application fees for future drug development. In 2022, the application fee for a human drug application will cost $1.6 million for drugs that don’t require clinical data and $3.1 million for medicines that do need clinical data.
Competition and innovation lead to lower prices, not government pricing schemes. Patients should be confident their medicine is safe, effective, and accessible. The U.S. cannot remain the world leader on drug research and development and provide safe and effective medicines by instituting price controls or importing drugs from foreign countries with socialist health care systems.
Christina Herrin is director of Health and Science Policy at Citizens Against Government Waste.
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